There has been a recent flurry of activity surrounding injunctive relief in the Edwards LifeSciences AG v. CoreValve, Inc. case, which involves aortic heart valve replacement technology. Edwards filed suit in 2008, alleging that Defendants Corevalve and Medtronic infringe its patents. In 2010 a jury returned a judgment of infringement in favor of Edwards against Medtronic, awarding lost profits and reasonable royalty damages, and the Federal Circuit later affirmed. In late 2013, Edwards moved for a preliminary injunction to stop what it alleged would be Medtronic’s infringement once Medtronic obtained FDA approval for its new “CoreValve Generation 3” product. Chief Judge Sleet held an evidentiary hearing on the “public interest factor of the preliminary injunction motion” on April 11 and issued a written decision on April 15 explaining his oral order at the hearing granting in part and denying in part the preliminary injunction. Edwards Lifesciences AG, et al. v. CoreValve, Inc., et al., C.A. No. 08-91-GMS, Memo. at 1-2 (D. Del. Apr. 15, 2014).
Edwards and Medtronic both make transcatheter heart valves that allow implanting of prosthetic aortic valves using a catheter thereby avoiding open heart surgery. The two companies are each other’s only competitors in the United States. Each company manufactured an older, predecessor type of transcatheter heart valve, and each company sought FDA approval of a new type of transcatheter heart valve. Although the FDA had not yet approved the product, the 2010 jury verdict of infringement related to Medtronic’s newer product, the CoreValve Generation 3. Before FDA approval of Medtronic’s infringing product, Medtronic had been able to make it available to patients through a continued access clinical trial. In January, however, the FDA approved the sale of the Medtronic product, which ended the continued clinical trial. Accordingly, Medtronic sought to begin commercially selling its CoreValve Generation 3 product. Edwards expected to obtain FDA approval for its new competing product and begin selling it in the near future as well. Id. at 2-4.
Chief Judge Sleet ultimately granted the motion for preliminary injunction in part. In doing so, he faced several legal and practical issues. With regard to the likelihood of success on the merits, Judge Sleet faced a question regarding enforceability, given that the patent-in-suit had expired in the years since the jury verdict. The FDA, however, had granted an interim extension of patent rights under 35 U.S.C. § 156. Medtronic argued that Edwards’ extension was limited to copies of its old product, not to copies of its new product like Medtronic’s CoreValve Generation 3. Therefore, Medtronic argued, even though its Generation 3 product might infringe the patent-in-suit, it is different from the Edwards product on which the term extension of that patent was based. Judge Sleet did not accept this argument, finding that Section 156(b) addressed approved uses, not approved products. Thus, because the accused Generation 3 product had the same use as the original Edwards approved product, the patent term extension covers it. Thus, having prevailed on infringement and had its patent term extended, Edwards had shown a likelihood of success on the merits. Id. at 5-6.
Judge Sleet also concluded that Edwards had shown irreparable harm through potential price erosion and loss of sales, market share, and revenue. Id. at 6-13. The major argument from Medtronic against irreparable harm was that there exists a “countervailing consideration sufficient to trump the mandate that patent rights be enforced.” This public interest consideration is the possibility that enjoining Medtronic would “leave patients so at risk of inferior care or no care at all that the public interest requires Medtronic be allowed to sell the CoreValve Generation 3.” Id. at 13-14. Medtronic essentially argued that its product was a safer, superior alternative to Edwards’ products and that it should be permitted to continue selling its product to a class of patients regarded as “extreme risk” because in some cases those patients could not be helped by Edwards’ existing product or in other cases could not be helped by either Edwards’ existing product or its product being approved by the FDA. Judge Sleet rejected the first extreme risk patient argument because Edwards’ new product should be approved by the FDA in the near future. But Judge Sleet accepted the second argument, finding that “the public interest requires making some accommodation that would grant patients [who can only be treated by Medtronic’s devices] access to the CoreValve Generation 3.” Thus, Judge Sleet granted the motion for preliminary injunction in part, concluding that the injunction must be tailored because “the public interest weighs in favor of granting Edwards a preliminary injunction, subject to an accommodation for Medtronic to sell its devices to those patients who cannot be helped by Edwards’ devices.” Id. at 14-21.
Judge Sleet also granted Medtronic’s request for “a stay of seven business days to ‘seek emergency relief in the Federal Circuit’ and ‘give hospitals some notice of what ha[d] happened.’” Id. at 2 n.4. Medtronic then filed an emergency motion with the Federal Circuit asking the court to stay the injunction. Medtronic urged the same arguments in the Federal Circuit as it had in the District of Delaware: public interest weighs in favor of denying injunctive relief and the patent is not enforceable because it has expired. The Federal Circuit agreed on April 15 to expedite the appeal and issued a decision on Monday, April 21 staying enforcement of the preliminary injunction. The Federal Circuit panel granted Medtronic’s motion to stay “pending further notice by this court” in a 2-1 order that did not further explain its rationale. Circuit Judges Rader, Prost, and Newman sat on the panel, with Judge Newman dissenting. The Federal Circuit will now review the preliminary injunction on the merits.